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Oxaliplatin in Unresectable Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have histologically confirmed hepatocellular carcinoma Patients must have measurable disease by CT scan Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy. The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds. WHO performance status: 0 to 2 Patients must have adequate organ and marrow function as defined below: Leukocytes : ≥ 3,000/μl Absolute neutrophil count :≥ 1,500/μl Platelets : ≥ 80,000/μl Total bilirubin : < 3.0g/dl ASAT/ALAT : ≤ 3 times the upper normal limits of the institute Creatinine : < 120μmol/l Patients with no evidence of clinically significant neuropathy. Exclusion Criteria: Documented allergy to platinum compound or to others study's drugs Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception) Hematological disorder or malignancies Metastasis to central nervous system Other serious illness or medical conditions: Active infectious disease Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia. Concurrent treatment with any other anticancer therapy Concurrent treatment with other experimental drugs. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST

    Secondary Outcome Measures

    Adverse Events collections and evaluation

    Full Information

    First Posted
    January 20, 2006
    Last Updated
    September 14, 2009
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00280618
    Brief Title
    Oxaliplatin in Unresectable Hepatocellular Carcinoma
    Official Title
    Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    Brief Summary
    Primary: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin Secondary: Safety and tolerability of this regimen in these patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Hepatocellular

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Primary Outcome Measure Information:
    Title
    Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
    Time Frame
    During the Study Conduct
    Secondary Outcome Measure Information:
    Title
    Adverse Events collections and evaluation
    Time Frame
    From the signature of the informed consent up to the end of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have histologically confirmed hepatocellular carcinoma Patients must have measurable disease by CT scan Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy. The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds. WHO performance status: 0 to 2 Patients must have adequate organ and marrow function as defined below: Leukocytes : ≥ 3,000/μl Absolute neutrophil count :≥ 1,500/μl Platelets : ≥ 80,000/μl Total bilirubin : < 3.0g/dl ASAT/ALAT : ≤ 3 times the upper normal limits of the institute Creatinine : < 120μmol/l Patients with no evidence of clinically significant neuropathy. Exclusion Criteria: Documented allergy to platinum compound or to others study's drugs Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception) Hematological disorder or malignancies Metastasis to central nervous system Other serious illness or medical conditions: Active infectious disease Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia. Concurrent treatment with any other anticancer therapy Concurrent treatment with other experimental drugs. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pingkuan Zhang
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Oxaliplatin in Unresectable Hepatocellular Carcinoma

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